Everolimus tablets recalled for out of specification impurity in one lot
Endo USA is recalling 1,041 cartons of Everolimus tablets 5mg after the lot returned an out-of-specification result for impurity IP-C.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as an FDA Class III specification failure, which the rubric places at 1 or 2; no health consequence or injury is described.
Plain-English summary
Everolimus tablets 5mg, in cartons of 28 tablets (four blister strips of seven), manufactured by Par Pharmaceutical of Chestnut Ridge, New York, are being recalled for failed impurities and degradation specifications, specifically an out-of-specification result for impurity IP-C.
The recall covers 1,041 cartons from lot 550172301, expiring January 2026, carrying NDC 49884-125-91. The product was distributed nationwide in the United States. The FDA has classified the recall as Class III.
The enforcement record names the impurity but does not describe a health consequence, and reports no injuries.
Everolimus is a prescription medicine, so patients holding the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
- Manufacturer
- Endo USA, Inc.
- Category
- Drug — Immunosuppressant
- Affected units
- 1,041
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 550172301
- Exp. Date January 2026
Distribution
Distributed nationwide across the United States.
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